Amauri G. S. Santamaría

Study Manager Clinical Development, numares AG

Urinary bladder cancer (BCa) is a malignant tumour that usually develops in the mucous membrane (urothelial carcinoma) of the bladder. The symptoms are relatively unspecific. One of the earliest cardinal symptoms of BCa is microscopically detectable haematuria, so-called microhaematuria, [1]. However, microhaematuria commonly has benign causes, such as infection, benign prostate enlargement or kidney stones, and is caused by malignant tumors only in 2 - 5 % of cases [2]. The key issue in the management of microhaematuria is therefore to reliable detect rare malignant bladder tumors among common benign diseases [3]. Since urinary cytology and current available urinary markers lack sufficient clinical reliability, cystoscopy in combination with biopsy and trans-urethral resection of the bladder (TURB) are considered the gold standard for the diagnosis of bladder tumors [4,5] and frequently used for urologic evaluation of persistent microhaematuria. However, these examinations are invasive, expensive [1] and unnecessary for the majority of patients with microhaematuria. Those would greatly benefit from a non-invasive, metabolomics-based test that reliable detects bladder cancer in microhaematuria and – when used as triage to cystoscopy – would help reduce unnecessary diagnostic procedures.

Material: Urine and serum samples from patients scheduled for cystoscopy or TURB due to persistent microhaematuria

Reference standard: Bladder cystoscopy in combination with biopsy or trans-urethral resection of the bladder (TURB)

Approach: Over the past 20 years, a variety of molecular markers has been proposed for the detection of BCa in patients with persistent microhaematuria to meet the medical need for a triage test to reduce unnecessary cystoscopies [3]. None of the new markers is currently well established in clinical routine. Transferred to a heterogeneous patient population with multiple causes of microhaematuria, only a pattern with multiple markers is likely to provide sufficient diagnostic accuracy to exclude bladder cancer as a cause of microhaematuria. With the AXINON® platform, numares has a reliable, fast and flexible analysis system for the simultaneous acquisition of several hundred metabolites in a single analytical step. The metabolomics approach will now provide initial insights into the processes and metabolic changes in in bladder cancer. This will be the basis for developing a non-invasive, metabolomics-based test for bladder detection in microhaematuria.

Success: In-house preliminary work identified a metabolite constellation that allows detection of BCa by NMR analysis of urine.

Our Success. |Innovative Diagnostic Products.

Objective: Development and validation of an NMR based metabolite constellation determining glomerular filtration rate for a more accurate picture of the underlying kidney function.

“A diagnostic test as precise as mGFR, as simple as eGFR, and fit for clinical routine“,Dr. Eric Schiffer, Head of Clinical Development, numares AG

The glomerular filtration rate (GFR) is the most important parameter in assessing kidney function. The gold standard to determine GFR is inulin clearance [1, 2], but other substances have been explored for measuring GFR (mGFR) as well [3]. Although very precise, mGFR methods are expensive, time-consuming and therefore impractical in routine. Therefore, GFR is mostly estimated by a simple serum creatinine analysis (eGFR) [4]. However, serum creatinine levels strongly depend on patient’s individual features...

Objective: Quantitative evaluation of the diagnostic accuracy (AUC value, sensitivity, and specificity) of AXINON® renalTX-SCORE-U100® for the detection of acute renal allograft rejections

“A non-invasive diagnostic test for close-monitoring of kidney transplant patients and minimizing the number of potential graft-harming biopsies for earliest therapy intervention to preserve the kidney“,Dr. Eric Schiffer, Head of Clinical Development, numares AG

Kidney transplantation is the treatment method of choice for patients with terminal kidney failure [1]. Transplant patients require frequent follow-up examinations to detect potential complications at an early stage. Therefore, biopsies are performed during aftercare. They are generally considered to be safe, but it remains an invasive procedure with a risk...

Hepatocellular carcinoma (HCC) is an aggressive tumor of the liver with annual incidence of 1-6% in at risk patients with liver cirrhosis [1, 2]). Most patients have symptoms only in advanced stage HCC, impeding early detection of the tumor. The 5-year survival rate is <10% if HCC is diagnosed after symptoms...

Objective: Development and Validation of an NMR-based metabolite constellation that early indicates the transition of relapsing-remitting (RRMS) to secondary progressive multiple sclerosis (SPMS).

“A serum-based test for early diagnosis of the RRMS-to-SPMS transition to allow timely therapy adjustment”Dr. Eric Schiffer, Head of Clinical Development, numares AG

Multiple sclerosis (MS) is considered to be an immune-mediated disease in which the body’s own defence cells attack the central nervous system. MS involves inflammatory and neurodegenerative processes that damage the insulating myelin sheaths of nerve fibers and the nerve cells themselves. While about 10-15% of patients begin the disease with primary progressive MS (PPMS) showing continuously worsening of symptoms from disease onset, the majority of patients are initially diagnosed...

We use cookies to make interactions with our websites and services easy and meaningful, to better understand how they are used and to tailor advertising. You can read more and make your cookie choices here. By continuing to use this site you are giving us your consent to do this. Okay